A new clinical trial is investigating whether patients with ductal carcinoma in situ (DCIS) should undergo less aggressive treatment — findings that could affect the care of tens of thousands of women diagnosed each year with this non-invasive form of breast cancer.
The trial — available through Sharp HealthCare and about 100 other cancer centers in the United States — is the first study of its kind to compare treatments for DCIS, a grouping of abnormal cells inside the milk ducts of a breast.
The disease is often called stage 0 breast cancer because the cells have not spread beyond the milk ducts. In the U.S., more than 60,000 women are diagnosed each year with DCIS, accounting for about 1 in 5 breast cancers.
Women with DCIS typically undergo the same treatment offered to patients with invasive breast cancer — a lumpectomy to remove the abnormal tissue from the breast, followed by radiation. A mastectomy is sometimes recommended if the disease is widespread in the milk ducts, or patients can choose to have a mastectomy as a preventive measure.
Deciding which surgery, if any, to undergo can be difficult for women, says Dr. Christina Casteel, medical director for the Breast Health Center at Sharp Memorial Hospital. Surgery can also lead to side effects such as long-term pain, scarring, loss of feeling and negative body image.
“Studies suggest that only about 30 percent of DCIS cases will progress to invasive cancer, so it’s important for doctors to have more clarity about whether we are overtreating DCIS under current recommendations,” Dr. Casteel says. “This clinical trial will help us get closer to that answer.”
The trial — called Comparison of Operative to Monitoring and Endocrine Therapy, or COMET — will compare the standard approach of surgery and radiation to active surveillance, when a woman is watched closely over time to see if the DCIS progresses.
Based out of Duke University, the trial aims to recruit 900 women with low-risk DCIS — typically women older than 40, with low-grade DCIS, who have no personal history of breast cancer. Patients who qualify to participate will be randomly assigned to either the surveillance group or the group receiving standard treatments.
Women in the surveillance group will see their doctor regularly and will receive mammograms every six months. If a woman develops invasive cancer during the trial, she can move into the standard treatment group. In both groups, women can receive endocrine therapy — medicines that stop hormones from helping breast cancer cells grow.
All participants will be monitored for anxiety, depression and other health-related, quality-of-life measures up to two years following their diagnosis.
Sharp HealthCare will enroll qualified participants at its three hospital sites: Sharp Memorial Hospital, Sharp Grossmont Hospital and Sharp Chula Vista Medical Center. The study will last a minimum of five years. Patients in either group can leave the study at any time.
For the news media: To talk with Dr. Casteel about breast cancer research for an upcoming story, contact Erica Carlson, senior public relations specialist, at email@example.com.